DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 08/10/2026, 04/28/2026 and 02/27/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Kanetani et al. (JP 2007-155344 A; the prior art provided by applicant) in view of Yamaguchi et al. (US PAP 2015/0279649 A1) and Ikegami (US PAP 2021/0057200 A1).
With respect to claim 1, Kanetani et al. teaches a method executed by a computer for correcting a mass spectrum in mass spectrometry of a microorganism sample containing a target substance that is a molecule to be analyzed, the method comprising (see abstract; Figs. 1-3; paragraphs 0001-0003, 0062-0064 and 0077): obtaining a mass spectrum of the microorganism sample to which one or more types of molecules having a smaller theoretical m/z than the target substance are added as a first standard substance (see paragraphs 0001-0003, 0062-0064 and 0077); setting, as a second standard substance, one or more types of molecules derived from the microorganism sample and having a larger theoretical m/z than the target substance (see paragraphs 0001-0003, 0062-0064 and 0077); and correcting the mass spectrum based on an actual m/z of the first standard substance corresponding to peaks of the mass spectrum and an actual m/z of the second standard substance corresponding to peaks of the mass spectrum, and the theoretical m/z of the first standard substance and the theoretical m/z of the second standard substance (see abstract; Figs. 1-3; paragraphs 0001-0003, 0062-0064 and 0077; wherein Kanetani et al. teaches a method wherein the value of each peak position data included in the spectrum data is corrected on the basis of a detected peak (corresponding to the "measured m/z") derived from the internal standard and peak correction position data (corresponding to the "theoretical m/z") stored in the memory using a sample containing M internal standard substances (see paragraphs 0063 and 0064). Furthermore, as an example of the internal standard substance, document 1 (paragraph 0077) lists 2,4- dichlorophenoxyacetic acid (precision ion molecular weight = 218.96212), ampicillin (precision ion molecular weight = 348.10235), CHAPS (precision ion molecular weight = 613.38920), and tctra-N-acctylchitotetraosc (precision ion molecular weight = 829.32078), and a person skilled in the art could, as appropriate, select a compound having a molecular weight within these ranges as the specific compound to be measured.)
Kanetani et al. teaches correction but fails to explicitly mention calibrating the mass spectrum.
Yamaguchi discloses a system/method for mass analysis and mass calibration (see abstract; Figs. 1-5E; paragraphs 0002, 0004, 0039, 0053, 0058, 0065, 0072 and 0073), which explicitly teaches that it is known calibrating the mass spectrum based on an actual m/z of the standard substances corresponding to peaks of the mass spectrum and the theoretical m/z of the first standard substance and the theoretical m/z of the second standard substance (see paragraphs 0004, 0039, 0065 and 0072) in order to provide user with the process of comparing readings against a known traceable reference standard to document errors or deviation by improved calibration accuracy without automatically changing the device (see abstract; Figs. 1-5E; paragraphs 0002, 0004, 0039, 0053, 0058, 0065, 0072 and 0073).
Ikegami discloses a mass spectrometer and mass calibration method (see abstract; Figs. 1-10A; paragraphs 0015, 0020, 0030, 0072, 0077 and 0089-0095; claims 1, 2 and 7) which explicitly teaches calibrating the mass spectrum based on an actual m/z of the standard substances corresponding to peaks of the mass spectrum and the theoretical m/z of the first standard substance and the theoretical m/z of the second standard substance (see paragraphs 0015 and 0020) in order to provide user with improved calibration accuracy without automatically changing the device (see abstract; paragraphs 0015 and 0020).
Kanetani et al., Yamaguchi and Ikegami disclose related methods/apparatuses for mass spectrometry.
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains to provide teachings of calibrating the mass spectrum based on an actual m/z of the standard substances corresponding to peaks of the mass spectrum and the theoretical m/z of the first standard substance and the theoretical m/z of the second standard substance as suggested by Yamaguchi and Ikegami in the method of Kanetani et al., since such a modification would provide user with the capabilities of calibrating the mass spectrum based on an actual m/z of the first standard substance corresponding to peaks of the mass spectrum and an actual m/z of the second standard substance corresponding to peaks of the mass spectrum, and the theoretical m/z of the first standard substance and the theoretical m/z of the second standard substance with improved accuracy.
It would have been obvious to treat Kanetani et al., Yamaguchi and Ikegami as related art whereby an improvement on one of the systems/methods would readily be apparent as an improvement on either of the systems.
The Examiner’s conclusion that claim 1 would have been obvious is based on the fact that all the claimed elements were known in the prior art, that one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and that the combination teaches nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. 398, 82 USPQ2d at 1385 (2007); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson ’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).
With respect to claim 2, Kanetani et al. (see abstract; Figs. 1-3; paragraphs 0001-0003, 0062-0064 and 0077) as modified by Yamaguchi (see abstract; Figs. 1-5E; paragraphs 0002, 0004, 0039, 0053, 0058, 0065, 0072 and 0073) and Ikegami (see abstract; Figs. 1-10A; paragraphs 0015, 0020, 0030, 0072, 0077 and 0089-0095; claims 1, 2 and 7) teaches the calibration method according to claim 1, wherein the calibrating includes calibrating the mass spectrum in such a manner as to reduce a sum of a square of a difference between the actual m/z and the theoretical m/z of the first standard substance and a square of a difference of an error between the actual m/z and the theoretical m/z of the second standard substance (see abstract; Figs. 1-3; paragraphs 0001-0003, 0062-0064 and 0077).
With respect to claim 3, Kanetani et al. (see abstract; Figs. 1-3; paragraphs 0001-0003, 0062-0064 and 0077) as modified by Yamaguchi (see abstract; Figs. 1-5E; paragraphs 0002, 0004, 0039, 0053, 0058, 0065, 0072 and 0073) and Ikegami (see abstract; Figs. 1-10A; paragraphs 0015, 0020, 0030, 0072, 0077 and 0089-0095; claims 1, 2 and 7) teaches the calibration method according to claim 1, wherein the first standard substance is a protein or peptide (see abstract; Figs. 1-3; paragraphs 0001-0003, 0062-0064 and 0077).
With respect to claim 4, Kanetani et al. (see abstract; Figs. 1-3; paragraphs 0001-0003, 0062-0064 and 0077) as modified by Yamaguchi (see abstract; Figs. 1-5E; paragraphs 0002, 0004, 0039, 0053, 0058, 0065, 0072 and 0073) and Ikegami (see abstract; Figs. 1-10A; paragraphs 0015, 0020, 0030, 0072, 0077 and 0089-0095; claims 1, 2 and 7) teaches the calibration method according to claim 1, wherein the first standard substance contains at least one of angiotensin 1, angiotensin 2, Bradykinin Fragment (1-7), P14R, ACTH fragment (18-39), and oxidized insulin B-chain (see abstract; Figs. 1-3; paragraphs 0001-0003, 0062-0064 and 0077).
With respect to claim 5, Kanetani et al. (see abstract; Figs. 1-3; paragraphs 0001-0003, 0062-0064 and 0077) as modified by Yamaguchi (see abstract; Figs. 1-5E; paragraphs 0002, 0004, 0039, 0053, 0058, 0065, 0072 and 0073) and Ikegami (see abstract; Figs. 1-10A; paragraphs 0015, 0020, 0030, 0072, 0077 and 0089-0095; claims 1, 2 and 7) teaches the calibration method according to claim 1, wherein the second standard substance contains a ribosome protein (see abstract; Figs. 1-3; paragraphs 0001-0003, 0062-0064 and 0077).
With respect to claim 6, Kanetani et al. (see abstract; Figs. 1-3; paragraphs 0001-0003, 0062-0064 and 0077) as modified by Yamaguchi (see abstract; Figs. 1-5E; paragraphs 0002, 0004, 0039, 0053, 0058, 0065, 0072 and 0073) and Ikegami (see abstract; Figs. 1-10A; paragraphs 0015, 0020, 0030, 0072, 0077 and 0089-0095; claims 1, 2 and 7) teaches the calibration method according to claim 1, wherein the theoretical m/z of the second standard substance is calculated based on an amino acid sequence of the second standard substance (see abstract; Figs. 1-3; paragraphs 0001-0003, 0062-0064 and 0077).
With respect to claim 7, Kanetani et al. (see abstract; Figs. 1-3; paragraphs 0001-0003, 0062-0064 and 0077) as modified by Yamaguchi (see abstract; Figs. 1-5E; paragraphs 0002, 0004, 0039, 0053, 0058, 0065, 0072 and 0073) and Ikegami (see abstract; Figs. 1-10A; paragraphs 0015, 0020, 0030, 0072, 0077 and 0089-0095; claims 1, 2 and 7) teaches the calibration method according to claim 1, wherein the theoretical m/z of the second standard substance is estimated based on an actual m/z of the second standard substance having been previously measured by an internal standard method (see abstract; Figs. 1-3; paragraphs 0001-0003, 0062-0064 and 0077).
With respect to claim 8, Kanetani et al. (see abstract; Figs. 1-3; paragraphs 0001-0003, 0062-0064 and 0077) as modified by Yamaguchi (see abstract; Figs. 1-5E; paragraphs 0002, 0004, 0039, 0053, 0058, 0065, 0072 and 0073) and Ikegami (see abstract; Figs. 1-10A; paragraphs 0015, 0020, 0030, 0072, 0077 and 0089-0095; claims 1, 2 and 7) teaches an analysis method further comprising analyzing the target substance based on a mass spectrum having been calibrated by employing the calibration method according to claim 1 (see abstract; Figs. 1-3; paragraphs 0001-0003, 0062-0064 and 0077).
With respect to claim 9, Kanetani et al. (see abstract; Figs. 1-3; paragraphs 0001-0003, 0062-0064 and 0077) as modified by Yamaguchi (see abstract; Figs. 1-5E; paragraphs 0002, 0004, 0039, 0053, 0058, 0065, 0072 and 0073) and Ikegami (see abstract; Figs. 1-10A; paragraphs 0015, 0020, 0030, 0072, 0077 and 0089-0095; claims 1, 2 and 7) teaches a controller that executes correction of a mass spectrum in mass spectrometry of a microorganism sample containing a target substance that is a molecule to be analyzed, the controller comprising (see abstract; Figs. 1-3; paragraphs 0001-0003, 0062-0064 and 0077): a memory that stores a theoretical m/z of a first standard substance that is one or more types of molecules having a smaller theoretical m/z than the target substance; and a processor, wherein the processor is configured to obtain a mass spectrum of the microorganism sample to which the first standard substance is added; set, as a second standard substance, one or more types of molecules derived from the microorganism sample and having a larger theoretical m/z than the target substance; and correct the mass spectrum based on an actual m/z of the first standard substance corresponding to peaks of the mass spectrum and an actual m/z of the second standard substance corresponding to peaks of the mass spectrum, and the theoretical m/z of the first standard substance and the theoretical m/z of the second standard substance (see abstract; Figs. 1-3; paragraphs 0001-0003, 0062-0064 and 0077).
Kanetani et al. teaches correction but fails to explicitly mention calibrating the mass spectrum.
Yamaguchi discloses a system/method for mass analysis and mass calibration (see abstract; Figs. 1-5E; paragraphs 0002, 0004, 0039, 0053, 0058, 0065, 0072 and 0073), which explicitly teaches that it is known calibrating the mass spectrum based on an actual m/z of the standard substances corresponding to peaks of the mass spectrum and the theoretical m/z of the first standard substance and the theoretical m/z of the second standard substance (see paragraphs 0004, 0039, 0065 and 0072) in order to provide user with the process of comparing readings against a known traceable reference standard to document errors or deviation by improved calibration accuracy without automatically changing the device (see abstract; Figs. 1-5E; paragraphs 0002, 0004, 0039, 0053, 0058, 0065, 0072 and 0073).
Ikegami discloses a mass spectrometer and mass calibration method (see abstract; Figs. 1-10A; paragraphs 0015, 0020, 0030, 0072, 0077 and 0089-0095; claims 1, 2 and 7) which explicitly teaches calibrating the mass spectrum based on an actual m/z of the standard substances corresponding to peaks of the mass spectrum and the theoretical m/z of the first standard substance and the theoretical m/z of the second standard substance (see paragraphs 0015 and 0020) in order to provide user with improved calibration accuracy without automatically changing the device (see abstract; paragraphs 0015 and 0020).
Kanetani et al., Yamaguchi and Ikegami disclose related methods/apparatuses for mass spectrometry.
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains to provide teachings of calibrating the mass spectrum based on an actual m/z of the standard substances corresponding to peaks of the mass spectrum and the theoretical m/z of the first standard substance and the theoretical m/z of the second standard substance as suggested by Yamaguchi and Ikegami in the apparatus of Kanetani et al., since such a modification would provide user with the capabilities of calibrating the mass spectrum based on an actual m/z of the first standard substance corresponding to peaks of the mass spectrum and an actual m/z of the second standard substance corresponding to peaks of the mass spectrum, and the theoretical m/z of the first standard substance and the theoretical m/z of the second standard substance with improved accuracy.
It would have been obvious to treat Kanetani et al., Yamaguchi and Ikegami as related art whereby an improvement on one of the systems/methods would readily be apparent as an improvement on either of the systems.
The Examiner’s conclusion that claim 9 would have been obvious is based on the fact that all the claimed elements were known in the prior art, that one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and that the combination teaches nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. 398, 82 USPQ2d at 1385 (2007); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson ’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).
With respect to claim 10, Kanetani et al. (see abstract; Figs. 1-3; paragraphs 0001-0003, 0062-0064 and 0077) as modified by Yamaguchi (see abstract; Figs. 1-5E; paragraphs 0002, 0004, 0039, 0053, 0058, 0065, 0072 and 0073) and Ikegami (see abstract; Figs. 1-10A; paragraphs 0015, 0020, 0030, 0072, 0077 and 0089-0095; claims 1, 2 and 7) teaches an analyzer that performs mass spectrometry of a microorganism sample containing a target substance that is a molecule to be analyzed, comprising: a detector that obtains measurement data of the microorganism sample; and the controller according to claim 9 (see abstract; Figs. 1-3; paragraphs 0001-0003, 0062-0064 and 0077).
With respect to claim 11, Kanetani et al. (see abstract; Figs. 1-3; paragraphs 0001-0003, 0062-0064 and 0077) as modified by Yamaguchi (see abstract; Figs. 1-5E; paragraphs 0002, 0004, 0039, 0053, 0058, 0065, 0072 and 0073) and Ikegami (see abstract; Figs. 1-10A; paragraphs 0015, 0020, 0030, 0072, 0077 and 0089-0095; claims 1, 2 and 7) teaches a method executed by a computer for correcting a mass spectrum in mass spectrometry of a microorganism sample containing a target substance that is a molecule to be analyzed, the method comprising: obtaining a mass spectrum of the microorganism sample to which one or more types of molecules having a smaller theoretical m/z than the target substance are added as a standard substance; and correcting the mass spectrum based on an actual m/z of the standard substance corresponding to peaks of the mass spectrum and the theoretical m/z of the standard substance (see abstract; Figs. 1-3; paragraphs 0001-0003, 0062-0064 and 0077).
Kanetani et al. teaches correction but fails to explicitly mention calibrating the mass spectrum.
Yamaguchi discloses a system/method for mass analysis and mass calibration (see abstract; Figs. 1-5E; paragraphs 0002, 0004, 0039, 0053, 0058, 0065, 0072 and 0073), which explicitly teaches that it is known calibrating the mass spectrum based on an actual m/z of the standard substances corresponding to peaks of the mass spectrum and the theoretical m/z of the first standard substance and the theoretical m/z of the second standard substance (see paragraphs 0004, 0039, 0065 and 0072) in order to provide user with the process of comparing readings against a known traceable reference standard to document errors or deviation by improved calibration accuracy without automatically changing the device (see abstract; Figs. 1-5E; paragraphs 0002, 0004, 0039, 0053, 0058, 0065, 0072 and 0073).
Ikegami discloses a mass spectrometer and mass calibration method (see abstract; Figs. 1-10A; paragraphs 0015, 0020, 0030, 0072, 0077 and 0089-0095; claims 1, 2 and 7) which explicitly teaches calibrating the mass spectrum based on an actual m/z of the standard substances corresponding to peaks of the mass spectrum and the theoretical m/z of the first standard substance and the theoretical m/z of the second standard substance (see paragraphs 0015 and 0020) in order to provide user with improved calibration accuracy without automatically changing the device (see abstract; paragraphs 0015 and 0020).
Kanetani et al., Yamaguchi and Ikegami disclose related methods/apparatuses for mass spectrometry.
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains to provide teachings of calibrating the mass spectrum based on an actual m/z of the standard substances corresponding to peaks of the mass spectrum and the theoretical m/z of the first standard substance and the theoretical m/z of the second standard substance as suggested by Yamaguchi and Ikegami in the method of Kanetani et al., since such a modification would provide user with the capabilities calibrating the mass spectrum based on an actual m/z of the standard substance corresponding to peaks of the mass spectrum and the theoretical m/z of the standard substance.
with improved accuracy.
It would have been obvious to treat Kanetani et al., Yamaguchi and Ikegami as related art whereby an improvement on one of the systems/methods would readily be apparent as an improvement on either of the systems.
The Examiner’s conclusion that claim 11 would have been obvious is based on the fact that all the claimed elements were known in the prior art, that one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and that the combination teaches nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. 398, 82 USPQ2d at 1385 (2007); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson ’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).
With respect to claim 12, Kanetani et al. (see abstract; Figs. 1-3; paragraphs 0001-0003, 0062-0064 and 0077) as modified by Yamaguchi (see abstract; Figs. 1-5E; paragraphs 0002, 0004, 0039, 0053, 0058, 0065, 0072 and 0073) and Ikegami (see abstract; Figs. 1-10A; paragraphs 0015, 0020, 0030, 0072, 0077 and 0089-0095; claims 1, 2 and 7) teaches the calibration method according to claim 11, wherein the standard substance is a protein or peptide (see abstract; Figs. 1-3; paragraphs 0001-0003, 0062-0064 and 0077).
With respect to claim 13, Kanetani et al. (see abstract; Figs. 1-3; paragraphs 0001-0003, 0062-0064 and 0077) as modified by Yamaguchi (see abstract; Figs. 1-5E; paragraphs 0002, 0004, 0039, 0053, 0058, 0065, 0072 and 0073) and Ikegami (see abstract; Figs. 1-10A; paragraphs 0015, 0020, 0030, 0072, 0077 and 0089-0095; claims 1, 2 and 7) teaches the calibration method according to claim 11, wherein the standard substance contains at least one of angiotensin 1, angiotensin 2, Bradykinin Fragment (1-7), P14R, ACTH fragment (18-39), and oxidized insulin B-chain (see abstract; Figs. 1-3; paragraphs 0001-0003, 0062-0064 and 0077).
With respect to claim 14, Kanetani et al. (see abstract; Figs. 1-3; paragraphs 0001-0003, 0062-0064 and 0077) as modified by Yamaguchi (see abstract; Figs. 1-5E; paragraphs 0002, 0004, 0039, 0053, 0058, 0065, 0072 and 0073) and Ikegami (see abstract; Figs. 1-10A; paragraphs 0015, 0020, 0030, 0072, 0077 and 0089-0095; claims 1, 2 and 7) teaches an analysis method comprising analyzing the target substance based on a mass spectrum having been calibrated by employing the calibration method according to claim 11 (see abstract; Figs. 1-3; paragraphs 0001-0003, 0062-0064 and 0077).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Mukaibatake (US PAP 2014/0299762 A1; see abstract; Figs. 1-6; paragraphs 0002, 0003, 0021, 0034, 0036, 0050 and 0053; claim 8), Wang et al. (US PAP 2010/0171032 A1; see abstract; Figs. 1-4; paragraphs 0007, 0010 and 0053) and Wang (US Patent 6,983,213 B2; see abstract; Figs. 1-16; column 4, line 5 – column 8, line 60) teach the variety of quantitative analysis methods using mass spectrometers and self-calibration approach for mass spectrometry.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IRAKLI KIKNADZE whose telephone number is (571)272-6494. The examiner can normally be reached 9:00 AM - 6:00 PM. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David J. Makiya can be reached at 571-272-2273. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Irakli Kiknadze
/IRAKLI KIKNADZE/
Primary Examiner, Art Unit 2884
/I.K./ August 24, 2026
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